QA - Executive

6 days ago

Nandesari Vadodara Gujarat, India Farmson Basic Drugs Pvt Ltd Full time

**Job Title**: Quality Assurance Executive - Analytical Review

**Department**: Quality Assurance
**Location**: Nandesari,Vadodara
**Reporting To**: Manager - Quality Assurance

**Job Purpose**:
To ensure compliance with regulatory standards by reviewing analytical specifications, method validation protocols, audit trails, and investigating laboratory incidents and deviations. The role supports data integrity, GMP compliance, and continuous improvement in laboratory operations.

**Key Responsibilities:1. Specification Review**
- Review and approve analytical specifications for raw materials, intermediates, and finished products.
- Ensure specifications align with pharmacopeial standards and regulatory filings.

**2. Method Validation**
- Review method validation protocols and reports for analytical methods (e.g., HPLC, GC, UV).
- Ensure validation parameters (accuracy, precision, specificity, robustness) meet regulatory expectations.
- Coordinate with QC and R&D for method transfer and verification.

**3. Audit Trail Review**
- Conduct periodic and event-based audit trail reviews of computerized systems (e.g., Empower, Chromeleon).
- Ensure data integrity and compliance with 21 CFR Part 11 and EU GMP Annex 11.
- Document findings and escalate discrepancies to QA management.
- [pharmaguid...ines.co.uk]

**4. Lab Incidents & Deviations**
- Investigate laboratory incidents, OOS (Out of Specification), and OOT (Out of Trend) results.
- Perform root cause analysis and recommend CAPAs.
- Ensure timely closure of deviations and documentation in QMS.

**5. Documentation & Compliance**
- Maintain records of reviews, investigations, and approvals.
- Ensure compliance with internal SOPs, GMP, and regulatory guidelines.
- Support internal and external audits (e.g., USFDA, WHO, EU).

**Qualifications & Experience**:

- B.Pharm / M.Pharm / M.Sc. in Chemistry or related field.
- 3-6 years of experience in QA/QC in a regulated pharmaceutical environment.
- Hands-on experience with analytical instruments and software.
- Knowledge of regulatory guidelines (ICH, FDA, WHO, EU GMP).

**Job Types**: Full-time, Permanent

Pay: ₹556,901.17 - ₹973,785.18 per year

**Benefits**:

- Food provided
- Health insurance
- Provident Fund

Work Location: In person

  • QA - Executive

    2 weeks ago

    Nandesari, Vadodara, Gujarat, India Farmson Basic Drugs Pvt Ltd Full time ₹ 5,56,000 - ₹ 9,73,785 per year

    Job Title: Quality Assurance Executive – Analytical ReviewDepartment: Quality AssuranceLocation: Nandesari,VadodaraReporting To: Manager – Quality AssuranceJob Purpose:To ensure compliance with regulatory standards by reviewing analytical specifications, method validation protocols, audit trails, and investigating laboratory incidents and deviations. The...

  • QA/qc Executive

    4 days ago

    Vadodara, Gujarat, India krishna Enterprises Full time

    Job Profile: Overall planning of QA/QC department, Implementing systems as per BRC issue 8 guidelines, Facing external audits, Monitoring food safety-related documents, combining with ISO and BRC documentation. Company Profile: Manufacturer of food ingredients Salary Package: 14K- 25K Terms and Conditions or BOND, Service Agreement etc (if any):...

  • Executive QA/QC

    5 days ago

    Vadodara, India Pintola Full time

    We’re Hiring!Company: Das Superfoods Pvt. Ltd. (Pintola)Position: Executive QA/QCNo. of Positions: 2Location: HimmatnagarQualification & Experience:Bachelor’s degree in Food Science / Food Technology or a related field.2 years of experience in the food industry (preferably in QA/QC).Key Responsibilities:- Testing of raw materials, packaging materials,...

  • Executive QA

    13 hours ago

    Gujarat, India Hikal Full time

    Executive QA required for equipment qualification, utility, water system, HVAC qualification etc.

  • QA/qc Executive

    2 days ago

    Vadodara, Gujarat, India Unicrop Biochem Full time

    **Key Responsibilities**: - Conduct quality assurance and quality control tests for raw materials, in-process materials, and finished goods. - Ensure that products meet the company's quality specifications and regulatory standards. - Prepare and maintain QA/QC documentation, including test reports, compliance reports, and audit records. - Monitor and...

  • Junior Executive

    2 days ago

    Nandesari, India Acumen360 Consulting & HR Solutions Full time ₹ 5,00,000 - ₹ 15,00,000 per year

    Job Description:JOB DESCRIPTIONJob title:Quality Assurance ChemistName of job holder:Department/service:QA/QCSignature job holder & date:Signature hierarchical head & date:Manager - QASignature functional head & date:Head - QMA. Purpose /Role of the job /: Describe in 1 phrase what contribution the job is expected toMake to the organisation's objectives...

  • QA Executive

    2 weeks ago

    Ahmedabad, Gujarat, India Prodigy Placement LLP Full time

    **Position: QA Executive** **Department: Quality Assurance** **Industry: Pharmaceutical Manufacturing (Formulations / APIs as applicable)** **Location: Ahmadabad** **Reporting to: QA Manager / Head - Quality Assurance** **Role Overview**: We are seeking a detail-oriented **QA Executive**to ensure compliance with **cGMP, regulatory standards, and company...

  • QA Executive

    2 weeks ago

    Vadodara, India Rextone Industries Ltd. Full time

    Position Vacant - QA Executive Required no of Position’s - 01 Qualification Required - MSC (Chemistry) Experience - 1 to 2 years **Preferred : Female** - **Job Location: POR**_ Working Days: Monday to Saturday **Job Description: -** - Working exposure of instruments like Viscometer, tensio-meter, particle size analyzer, karl fischer, spectro...

  • QA/qc Executive

    6 days ago

    Savli, Vadodara, Gujarat, India Bizelite HR Private Limited Full time

    Job Description - Quality Manager (QC/QA) Department: Quality Control / Quality Assurance Position Overview The Quality Manager will be responsible for leading the Quality Control and Assurance functions across production units. The role involves establishing quality systems, ensuring compliance with ISO and client standards, and driving a culture of...

  • QA Executive

    1 week ago

    Ahmedabad, Gujarat, India VasyERP Solutions Full time

    **Job Overview**: We are seeking a detail-oriented and analytical **QA Executive** to join our growing product team. You will be responsible for ensuring that our software products are of the highest quality by designing and implementing test plans, identifying bugs, and improving testing processes. You will collaborate closely with developers, product...